OPGEN INC - OPGN STOCK NEWS

OpGen has issued a formal response to the FDA’s AI Requests for the Acuitas AMR Gene Panel pre-market submission, addressing all inquiries raised by the agency. Originally submitted in May 2019, the response was delayed due to COVID-19. The panel aims to detect over 40 diagnostic targets and is critical for addressing antimicrobial resistance in hospitals. OpGen anticipates swift FDA clearance and broader commercial availability in the U.S. to assist in tracking hospital superbugs, as it is already used in a New York State Department of Health collaboration.

OpGen, Inc. (Nasdaq: OPGN) announced a German Federal Government grant awarded to its subsidiary, Curetis GmbH, in collaboration with Jena University Hospital. This project focuses on developing AI-based assays for detecting carbapenem-resistance in Gram-negative bacteria, utilizing over 350,000 Euros in funding. Set to run from September 2020 to August 2025, the initiative targets improving diagnostics for challenging pathogens like Enterobacteria and Pseudomonas. The project aims to enhance detection of resistance mechanisms inadequately covered by current methods, promoting innovative approaches against antimicrobial resistance.

OpGen has announced the successful completion of a clinical study of its Unyvero HPN panel, aimed at detecting bacterial co-infections in COVID-19 pneumonia patients. Conducted in collaboration with Karolinska Institutet, the study demonstrated a remarkable 99.8% negative predictive value and reduced diagnostic turnaround times from days to less than 5 hours. The study involved 83 samples from 68 ICU patients, emphasizing the Unyvero HPN panel's potential for early diagnosis and effective antimicrobial stewardship in critically ill patients. This tool is essential for managing bacterial pneumonia co-infections among COVID-19 patients.

OpGen announced the successful completion of a clinical study for its Unyvero Hospitalized Pneumonia (HPN) panel, which rapidly detects bacterial co-infections in COVID-19 patients. The study showed a high negative predictive value of 99.8% and significantly reduced diagnostic turnaround time from days to under 5 hours. This advancement aids in early detection and supports antimicrobial stewardship, particularly crucial for high-risk patients. The study involved 83 samples from 68 subjects, highlighting the panel's efficacy in identifying critical pathogens often missed by traditional methods.

OpGen, Inc. (Nasdaq: OPGN) has shifted its 2020 Annual Meeting of Stockholders to its corporate headquarters in Gaithersburg, Maryland, amid ongoing COVID-19 health considerations. The meeting is scheduled for September 30, 2020, at 10 a.m. ET. Stockholders of record as of August 17, 2020, can vote until September 29, 2020. Attendees must notify the company by September 28 and adhere to health guidelines. OpGen specializes in molecular diagnostics and aims to improve patient outcomes in infectious disease treatment. For more details, visit their official website or SEC filings.

OpGen, Inc. (Nasdaq: OPGN) announced a peer-reviewed study from Ares Genetics and Johns Hopkins University on the modifiable risk factors for ceftolozane-tazobactam resistance in P. aeruginosa, published in Clinical Infectious Diseases. The study highlights the effectiveness of Next-Generation Sequencing (NGS) in understanding resistance mechanisms and suggests potential strategies to mitigate such resistance. Dr. Andreas Posch emphasized the diagnostic value of NGS and the potential for rapid antimicrobial susceptibility testing.

OpGen, Inc. (Nasdaq: OPGN) announced that its subsidiary, Ares Genetics, has been nominated for the 40th Austrian Innovation Award for its ARESupa – Universal Pathogenome Assay. This AI-powered molecular antibiotic susceptibility test is recognized among six finalists. The award highlights innovations that strengthen Austria's competitiveness amidst the COVID-19 crisis. ARESupa leverages whole-genome sequencing and ARESdb, a proprietary database covering over 55,000 bacterial strains. This award follows ARESupa's previous recognition with the MERCUR Innovation Award in Life Sciences.

OpGen (Nasdaq: OPGN) announced the results of a peer-reviewed study demonstrating the clinical utility of its Unyvero LRT Panel for pneumonia diagnosis. The study, published in the Journal of Diagnostic Microbiology & Infectious Disease, showed a high negative predictive value of 97.9%, enabling a 65.9% rate of antibiotic de-escalation when MRSA or Pseudomonas aeruginosa are absent. The panel identifies critical pathogens missed by traditional cultures, potentially improving antibiotic stewardship in hospitalized patients.